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FDA mandates new labels on OTC lice products
As summer days morph into back-to-school anxiety, parents can add one more worry to their growing catalog of concerns for their children: head lice. Thanks to increasing reports of lice's alleged resistance to treatments, the Food & Drug Administration has taken steps to foster lice awareness among the public in the hope that better understanding will prompt more successful lice eradication.
The action the FDA has taken is to mandate a change in the labeling on OTC lice treatment products. Many OTC drug manufacturers have begun displaying FDA's new, easier-to-read drug facts label on their products. Michael T. Benson, regulatory review pharmacist with the division of OTC drug products, FDA, explained the rationale for the change. "We were getting reports complaining about certain products not working. Based on references cited in our report, we decided to propose rewording labels on pediculicides. With more details and specifics, there is a greater possibility of treatment success."
The FDA's decision to revise the labeling suggests that pediculicide ineffectiveness may be a result of consumer misuse. Benson believes that "resistance is still up in the air, but it still hasn't been positively proven." After examining the results of the new labeling, the FDA may ascertain whether product inefficacy stems from consumer misuse or the drug's impotency.
Harry Upton, president of Care Technologies Inc., manufacturer of Clear Care Lice Treatments, feels the new labels are "a good idea. The nice thing is that now every drug label has the same information in the same place. The advantage from the consumers' standpoint is that all labels for all pediculicides are uniform: active ingredients first, then the warning, then the directions." This consistency should facilitate consumer awareness of what each medication entails, thus hopefully producing an overall improvement in efficacy.
One skeptic of this approach is Robert J. Pollack, Ph.D., instructor of tropical health, Department of Immunology & Infectious Diseases, Laboratory of Public Health Entomology at Harvard. He said, "Improved labels are useful, but they won't solve many of the problems. Too few consumers read the labels, and fewer seem to follow the guidance they offer." Arguing that many cases of head lice can be prevented with a more accurate understanding of its treatment, rather than use of a chemical product, Pollack advocated the value of reading as much literature on the subject as possible. His tips on lice prevention as well as an extensive overview of treatments available may be viewed on his Web site at www.hsph.harvard.edu/headlice.html.
The National Pediculosis Association (NPA) adopts a similar approach to lice treatment, urging parents not to immediately resort to chemical products upon suspicion of a lice infestation. NPA has developed "Jesse's Project 2002" to protect children diagnosed with serious illness from unnecessary exposure to the potentially harmful chemicals contained in pesticidal head lice treatments and environmental lice sprays for furniture and bedding. Jesse's Project promotes the LiceMeister Head Lice and Nit Removal Kit, which was launched this past June. The kit is a chemical-free set of treatment tools, including an instructional video, a LiceMeister comb, NPA tips for head lice and nit removal, and a Critter Card, a tool to help prevent confusion in identifying lice and nits versus common hair debris. In addition, the NPA will sponsor its 18th annual "All Out Comb Out," which will kick off in September for National Pediculosis Prevention Month. The event is designed to serve as a red flag for the influx of infestations common to the onset of school. Deborah Z. Altschuler, president of the NPA, advised, "No matter what you do, be sure to provide a nonchemical choice for children, families, and yourself." To learn more about the NPA and Jesse's Project, log on to www.headlice.org .
Although lice organizations are pushing nonchemical alternatives, many companies continue to introduce new chemical-based products. In June, Del Laboratories launched the Pronto Complete Lice Killing Kit, which includes Lice Killing Shampoo & Conditioner in One, Lice Killing Spray, Lice/Egg Comb, and Crème Rinse. Bayer Inc. has embraced both approaches to lice termination, producing Rid Lice Killing Shampoo and the Rid Dual Lice Comb. The comb hit shelves in May of this year. Care Technologies has followed up its Clear Neon Nits Spray with the April launch of Clear Not Nice to Lice Kit, which incorporates an enzyme-based mousse to "knock out" the lice, with an extra- fine comb for easy removal.
While the threat of lice infestation may be alarming, the increase of information on packages as well as through the Internet, along with the entry of new products, offers promising remedies to this ongoing menace.
Kristen Pollina. New pediculicide labels promote head lice awareness.